Hyperbaric Oxygen Therapy for Ulcerative Colitis

Description

Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.

Conditions

Ulcerative Colitis

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Study Overview

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Study Details

Study overview

Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.

Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial

Hyperbaric Oxygen Therapy for Ulcerative Colitis

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Medicine, Birmingham, Alabama, United States, 35233

Los Angeles

University of Los Angeles Health, Los Angeles, California, United States, 90024

Miami

University of Miami Health, Miami, Florida, United States, 33136

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Lake Forest

Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, United States, 60045

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Lebanon

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

New York

Cornell University Medical Center, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants with known or newly diagnosed UC who require hospitalization for an acute moderate to severe flare
  • * Age 18-85
  • * Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroids
  • * Complication requiring urgent surgical intervention
  • * Toxic megacolon
  • * Inability to receive intravenous steroids
  • * Historically failed 3 or more classes of advanced therapeutic options
  • * Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitis
  • * Received any investigational drug within 30 days
  • * Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment that increases the risk for HBOT toxicity
  • * Women who are pregnant or nursing
  • * Unwillingness to complete course of HBOT
  • * Active SARS CoV 2 infection

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Lauren Balmert Bonner, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

2027-09-01